Is Zanidatamab approved by the US FDA?

Drugs@FDA lists 1 application product line for Zanidatamab, including ZIIHERA (Prescription).

Is Zanidatamab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Zanidatamab: Ziihera.

Are there safety signals or safety updates for Zanidatamab?

US FDA: 1 entry (latest 2026-08-25).

Active substance

Zanidatamab

US FDA 1
EMA 1
Safety 1

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
ZIIHERA	300MG	injectable · injection	JAZZ PHARMS	Prescription	20 Nov 2024

EMA European Union — centrally authorised medicines

Ziihera Jazz Pharmaceuticals Ireland Limited · Authorised · authorised 27 Jun 2025 · ATC L01FD07

Therapeutic indication (EMA)

Ziihera as monotherapy is indicated for the treatment of adults with unresectable locally advanced or metastatic HER2-positive (IHC3+) biliary tract cancer (BTC) previously treated with at least one prior line of systemic therapy (for biomarker-based patient selection, see section 4.2).

Safety signals and safety-related labeling changes

US FDA 25 Aug 2026 ZIIHERA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for zanidatamab →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.